Status:
COMPLETED
Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD)
Lead Sponsor:
Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
HIV-infected Participants With ESRD Undergoing Routine Hemodialysis
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief Summary
Doravirine is a novel non-nucleoside reverse transcriptase inhibitor that has demonstrated good efficacy, tolerability, and safety for the treatment of patients with HIV infection in phase III clinica...
Detailed Description
Doravirine is a novel non-nucleoside reverse transcriptase inhibitor that has demonstrated good efficacy, tolerability, and safety for the treatment of patients with HIV infection in phase III clinica...
Eligibility Criteria
Inclusion
- Males and females\* aging ≥ 18 years.
- Documented HIV infection).
- Stable antiretroviral treatment for at least 2 weeks prior to enrolment.
- Optimal adherence to antiretroviral treatment, defined as less than 2 missed doses within the previousweek.
- End-stage renal disease in renal replacement therapy with periodic hemodialysis.
- Agree with the study procedures and signature of the informed consent. \*Women of childbearing potential must have a negative pregnancy test prior to randomization into the study and commitment to useat least one of these birth control methods: male or female condom with or without spermicide, cap, diaphragm or sponge with orwithout spermicide, intrauterine device, bilateral tubal occlusion, vasectomized partner, sexual abstinence during the study. Condomuse is considered as an additional method of contraception only and cannot be the only method of contraception used as not beenconsidered an effective method by the Clinical Trial Facilitation Group (CTFG) guidelines.
- Based on ICH, M3 (R2) 2009 a woman is considered of childbearing potential: fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include tubal ligation, hysterectomy, bilateral oophorectomy.
Exclusion
- Evidence or clinical suspicion that the patient will not be able to comply with the study protocol.
- Hypersensitivity to doravirine
- Concomitant therapy within the previous 4 weeks with any of the following drugs:
- Anticonvulsants: carbamazepine, oxcarbazepine, phenobarbital, phenytoin
- Androgen receptor inhibitor: enzalutamide
- Antimycobacterials: rifampin, rifapentine
- Cytotoxic agent: mitotane
- St. John's wort (Hypericum perforatum)
- Females who are pregnant or breastfeeding.
- ALT and/ or AST ≥ 4 times the upper limit of normal (ULN) at screening.
- Hemoglobin \< 7,5 g/dL at screening.
Key Trial Info
Start Date :
March 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04689737
Start Date
March 20 2021
End Date
June 14 2021
Last Update
August 27 2024
Active Locations (3)
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1
Germans Trias i Pujol Hospital
Badalona, Barcelona, Spain, 08916
2
Universitario Bellvitge Hospital
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
3
Valle Hebron Hospital
Barcelona, Spain, 08035